Red Yeast Rice Supplements-Can They Still Be Effective?

FDA Consistent in Restricting Sale of Lovastatin-Natural or Synthetic

Summary: Certain types of red yeast rice naturally contain lovastatin, the same active ingredient in Merck’s prescription statin medication Mevacor. Whether natural or synthetic, the FDA has consistently maintained that lovastatin has serious potential side effects and should remain a controlled (prescription) medication. As such, the FDA denied Merck’s multiple petitions to sell low-dose Mevacor on an over-the-counter basis. The FDA also has placed restrictions on red yeast rice supplements with verified levels of the naturally-occurring statin. For those interested in natural alternatives, certain nutrients, notably plant sterols, soluble fiber from oats, barley, beans, psyllium and fruit, Omega-3’s from marine sources, niacin, and monounsaturated fats replacing saturated fats, should be considered as an effective alternative approach.

Red Yeast Rice: A Particular Type is a Natural Statin

Red yeast rice is the product of yeast grown on rice. As a food, red yeast rice can be found as a paste, whole dried grains, or as a ground powder. In these forms, it has been a common food in certain Asian diets. In its traditional forms, red yeast rice contains no more than trace amounts of the active cholesterol-lowering agent. In fact, some types of red yeast rice contain no actives.

As a supplement, a particular type of enhanced red yeast rice was shown to significantly lower total cholesterol and LDL (bad) cholesterol. The active ingredient has been identified as lovastatin, the same as found in the popular statin drug, Mevacor and its generic equivalents.

Lovastatin, in turn, is a controlled prescription medication.

Can red yeast rice supplements offer benefit in comparison with prescribed statin medications?

For those preferring naturally-derived solutions, red yeast rice sources of statins could be preferred. This conceptually would be equivalent to a naturally-derived vitamin E as opposed to a synthetic. As we have further come to understand, the active agents in a natural product may be more bioavailable or more effective due to other compounds that accompany whole food. Yet, the FDA consistently views statins--natural or synthetic-- as powerful medication with potential side-effects and potential drug interactions. As such the FDA restricts the sale lovastatin, regardless of its source.

Most recently, the FDA rejected the petition of pharmaceutical giant Merck to offer Mevacor without a prescription. Merck has made three tries to have this statin sold over the counter. In rejecting Merck’s latest petition, the FDA indicated that too many of the wrong people would use the drug if it no longer required a prescription.

Last summer, the FDA issued warnings to consumers not to buy or eat certain red yeast rice products. FDA testing revealed the products contained lovastatin.

The FDA stated that “these red yeast rice products are a threat to health because lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.”


What’s in Red Yeast Rice Supplements Today?

Back in 1999, when the clinical studies on the efficacy of red yeast rice were first released, supplements with identified and controlled levels of the active compounds could be purchased. Today, however, such supplements cannot be produced. In fact, red yeast rice supplements may be made from the varieties of red yeast rice that does not the cholesterol-lowering compound. We simply do not know.

Natural Cholesterol Management Alternatives

The coupling of target levels of plant sterols (2-3g/day) and soluble fiber (10-25g/day) with a calorie-mindful diet replacing saturated and trans fats with monounsaturated fats can achieve results similar to many cholesterol-lowering medications. Niacin and omega-3s from fish oil also can play a role. Check with your health care professional about a complete program. Click Here to Learn More.

Kardea Gourmet Nutrition Bars---Now Available!

Just returned from the first full production run of our gourmet nutrition bars for cholesterol management. A great experience! As many of your know, we took great care in the formulation of these bars. The criteria was to create great taste, use only all-natural ingredient, deliver effective levels of key cholesterol-managing ingredients (plant sterols, soluble fiber, soy protein), maintan a low fat, particularly low saturated fat, standards, and create a lower glycemic profile. Thanks to everyone who has been involved in this process. As we all agree, we have created a breakthrough product.

The bars will be available through our online store starting on February 25, and a limited supply of variety packs also are available (first come, first served). Single-flavor 15 counts are available in banana walnut, lemon ginger, chai spice and cranberry almond.


Thanks to all who made this start-up a huge success. I have spent a career in food manufacturing, and you folks delivered as one of the best cross-functional teams in the business.

Kardea Nutrition-enabling natural cholesterol management, heart healthy and inspired.

And our collective best wishes for Rod's grand daughter's recovery and health.

Natural Cholesterol Management-Study Reaffirms Efficacy

A new study reaffirmed the recommendations of the medical community related to the power of nutrition to lower cholesterol independent of cholesterol-lowering medications.

"In the context of a low-saturated fat diet and in combination with other cholesterol-lowering dietary components, plant sterols appear to exert a very significant effect on LDL-C reduction of the order of 10 per cent for two grams per day of plant sterols," wrote lead author David Jenkins from St Michael's Hospital, Toronto."This figure is similar to studies where plant sterols have been given as the only cholesterol-lowering agent. "Numerous clinical trials in controlled settings have reported that daily consumption of 1.5 to 3 grams of phytosterols/stanols can reduce total cholesterol levels by eight to 17 per cent, representing a significant reduction in the risk of cardiovascular disease.

Participants in the new study adhered to the guidelines set out by the National Cholesterol Education Program Adult Treatment Panel III (ATP III). According to these guidelines, "therapeutic lifestyle changes" can achieve results similar to some cholesterol lowering medications. The study sought to assess the effectiveness of "each functional food component to the overall cholesterol reduction observed and whether all ingredients have to be present," explained the researchers. Jenkins and co-workers prescribed the 42 subjects (average age 63) to a diet containing viscous fibres (10 g/1,000 kcal), soy protein (22.5 g/1,000 kcal), and almonds (23 g/1,000 kcal) for 80 weeks. In addition, plant sterols were taken (one gram per 1,000 kcal), except during weeks 52 to 62.

"Increased plant sterol intakes are likely to have been a part of the ancestral human diet at about one gram per day and are part of a more plant-based diet as currently recommended for CHD risk reduction, including green leafy vegetables, raw or dry roasted nuts, and non-hydrogenated vegetable oils," wrote the authors. "Their reintroduction into the Western diet to prevent CHD may be seen as similar to the desire to reintroduce fibre into the diet to reduce the risk of a number of chronic diseases....Plant sterols therefore appear a good fit with other cholesterol-lowering components in a dietary portfolio to reduce CHD risk," they concluded.


D Jenkins et al. Effect of plant sterols in combination with other cholesterol-lowering foods.
Metabolism, Volume 57, Issue 1, Pages 130-139

Sources of Good Fats for Natural Cholesterol Management

Natural cholesterol managers seek to obtain 25-35% of their calories from fats, striving for zero trans fats, less than 7% from saturated fats, and no more than 10% and 20% of their calories from polyunsaturated and monounsaturated fats respectively. We have extolled the virtures of extra-virgin olive oil , but many people are asking us for more information on the levels of these fatty acids in the products they consume. Here is a good chart from the Harvard School of Public Health:

And if you are looking to build a framework for natural cholesterol managementt, consider our extra-virgin olive oil with added plant sterols (.5g plant sterols from plant sterol esters).